NCT07158996尚未招募1 期
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with SSc.
详细描述
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Sclerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICriteria: Inclusion Criteria:
- •18 to 75 years old at the time of signing the informed consent form (ICF)
- •Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria
- •Diffuse cutaneous SSc according to the LeRoy criteria
- •Positive for at least 1 SSc-specific parameter as specified in the protocol
- •Disease duration of ≤ 7 years
- •Inadequate response to therapies defined in the protocol.
排除标准
- •Inadequate clinical laboratory parameters at Screening
- •Receipt of or inability to discontinue any excluded therapies as specified in the protocol
- •Receipt of live vaccine within 4 weeks prior to Screening
- •Presence of any concomitant autoimmune disease other than the disease being studied
- •Receiving or anticipated to require total parenteral nutrition during the study
- •Active or history of intestinal pseudo-obstruction OR small intestinal bacteria overgrowth
- •Active or history of gastric antral vascular ectasia
- •Active digital ischemia with gangrene OR requiring antibiotics or amputation at Screening or during the study
- •Active or history of scleroderma renal crisis
- •History of progressive multifocal leukoencephalopathy
- •History of primary immunodeficiency or a hereditary deficiency of the complement system
- •Central nervous system (CNS) disease
- •Have presence of 1 or more significant concurrent medical conditions per investigator judgment
- •Have a diagnosis or history of malignant disease within 5 years prior to Screening
- •Inability to comply with contraception requirements as specified in the protocol
研究组 & 干预措施
A study of cizutamig in patients with Systemic Sclerosis (Ssc)
Experimental
干预措施: Biological: cizutamig (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study
时间窗: 52weeks
次要结局
未报告次要终点
研究者
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